EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking

NCT03262662

Last updated date
Study Location
State University of New York at Buffalo
Buffalo, New York, 14260, United States
Contact
716-645-0192

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tobacco Smoking
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Smoking at least 10 cigarettes per day for the past 6 months and expired-air carbon monoxide (CO) >7 at intake.

- At least moderately motivated to quit smoking and intention to make a quit attempt with varenicline 1 month after treatment begins.

- Planning to remain in western New York (NY) during the study period

- Willing to use varenicline and to refrain from other cessation treatments and tobacco products during the study period.

- English speaker

- To be intent-to-treat (ITT), the participant must complete Lab Visit 1 and meet minimal completion rate for real-world (EMA) assessments.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Use of other tobacco products, including e-cigarettes, in past 7 days


- Use of smoking cessation medication, including nicotine replacement therapy, in the
past 14 days


- Prior allergy/hypersensitivity to varenicline


- Pregnant or breast-feeding


- Substance use:


- Alcohol: AUDIT score > 15 at intake, suggestive of alcohol dependence and
warranting treatment; for those with scores between 8 and 15, the investigators
will advise reducing drinking).


- Medical treatment for substance use in past 3 months, including Suboxone
(buprenorphine) and methadone (at phone screen)


- Using a combination of the National Institute on Drug Abuse (NIDA) modified
ASSIST (4-26 = moderate risk; 27+ = high risk) and urine toxicology screen (both
at intake):


- Cannabis: ASSIST=27+ (tox screen not used)


- Cocaine: ASSIST=7+ OR positive tox screen


- Methamphetamine: ASSIST=7+ OR positive tox screen


- Inhalants, hallucinogens, sedatives, or sleeping pills: ASSIST score = 7+


- Prescription stimulants: With prescription, ASSIST 27+; Without
prescription, ASSIST 7+


- Opioids: With prescription, ASSIST 27+ (note ineligible if prescription is
for buprenorphine or methadone); Without prescription, ASSIST 7+ OR positive
tox screen


(Note: ASSIST 4+ modified to 7+ in 2018 to avoid excluding people with past SU problems.
clinicaltrials.gov edited 12/18/18)


- Psychiatric:


- Antipsychotic medications


- Lifetime history of schizophrenia or bipolar disorder


- Evidence of current major depression (per Patient Health Questionnaire (PHQ-9) at
intake


- Past 10 years suicidal ideation (SI) / behavior. At intake, all of the following
are exclusionary on the baseline Columbia-Suicide Severity Rating Scale (Posner
et al., 2008): SI without intent (C-SSRS #1, #2, or #3), if any intensity rating
(Frequency, Duration, Controllability, Deterrents, or Reasons for Ideation) is >
2; SI with intent (C-SSRS #4, or #5), regardless of intensity ratings; Suicidal
Behavior (any suicide attempt, interrupted attempt, aborted attempt, or suicide
preparatory acts or behavior on the C-SSRS).


- Any medical condition, illness, disorder or concomitant medication that compromises
participant safety or treatment, as determined by the Principal Investigator and/or
Study Physician.


- Inability to provide informed consent or complete any of the study tasks as determined
by the Principal Investigator and/or Study Physician.

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Tobacco SmokingEVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
NCT03262662
  1. Buffalo, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
Official Title  ICMJE EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
Brief Summary Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer period of varenicline treatment prior to the target quit date (TQD) will lead to greater reductions in smoking before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on promising preliminary clinical data, the study tests these hypotheses with a full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. The investigators further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: The project aims to make best available treatment for smoking cessation even better, using a method that is ripe for dissemination and an approach that will elucidate critical mechanisms to target in the next generation of treatment enhancement.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Smoking
Intervention  ICMJE
  • Drug: Varenicline
    oral varenicline tablets
    Other Name: Chantix
  • Behavioral: Brief smoking cessation counseling
    ~10-minute individual counseling at each of 6 clinic visits
Study Arms  ICMJE
  • Experimental: Extended Run-In

    ** 4 weeks of varenicline prior to the target quit date (TQD) **

    + 11 weeks of post-TQD varenicline

    Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.

    Brief individual counseling at clinic visits

    Interventions:
    • Drug: Varenicline
    • Behavioral: Brief smoking cessation counseling
  • Active Comparator: Standard Run-In

    ** 3 weeks of placebo followed by 1 week of varenicline prior to the target quit date (TQD) **

    + 11 weeks of post-TQD varenicline

    Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.

    Brief individual counseling at clinic visits

    Interventions:
    • Drug: Varenicline
    • Behavioral: Brief smoking cessation counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2017)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Smoking at least 10 cigarettes per day for the past 6 months and expired-air carbon monoxide (CO) >7 at intake.
  • At least moderately motivated to quit smoking and intention to make a quit attempt with varenicline 1 month after treatment begins.
  • Planning to remain in western New York (NY) during the study period
  • Willing to use varenicline and to refrain from other cessation treatments and tobacco products during the study period.
  • English speaker
  • To be intent-to-treat (ITT), the participant must complete Lab Visit 1 and meet minimal completion rate for real-world (EMA) assessments.

Exclusion Criteria:

  • Use of other tobacco products, including e-cigarettes, in past 7 days
  • Use of smoking cessation medication, including nicotine replacement therapy, in the past 14 days
  • Prior allergy/hypersensitivity to varenicline
  • Pregnant or breast-feeding
  • Substance use:

    • Alcohol: AUDIT score > 15 at intake, suggestive of alcohol dependence and warranting treatment; for those with scores between 8 and 15, the investigators will advise reducing drinking).
    • Medical treatment for substance use in past 3 months, including Suboxone (buprenorphine) and methadone (at phone screen)
    • Using a combination of the National Institute on Drug Abuse (NIDA) modified ASSIST (4-26 = moderate risk; 27+ = high risk) and urine toxicology screen (both at intake):

      • Cannabis: ASSIST=27+ (tox screen not used)
      • Cocaine: ASSIST=7+ OR positive tox screen
      • Methamphetamine: ASSIST=7+ OR positive tox screen
      • Inhalants, hallucinogens, sedatives, or sleeping pills: ASSIST score = 7+
      • Prescription stimulants: With prescription, ASSIST 27+; Without prescription, ASSIST 7+
      • Opioids: With prescription, ASSIST 27+ (note ineligible if prescription is for buprenorphine or methadone); Without prescription, ASSIST 7+ OR positive tox screen

(Note: ASSIST 4+ modified to 7+ in 2018 to avoid excluding people with past SU problems. clinicaltrials.gov edited 12/18/18)

  • Psychiatric:

    • Antipsychotic medications
    • Lifetime history of schizophrenia or bipolar disorder
    • Evidence of current major depression (per Patient Health Questionnaire (PHQ-9) at intake
    • Past 10 years suicidal ideation (SI) / behavior. At intake, all of the following are exclusionary on the baseline Columbia-Suicide Severity Rating Scale (Posner et al., 2008): SI without intent (C-SSRS #1, #2, or #3), if any intensity rating (Frequency, Duration, Controllability, Deterrents, or Reasons for Ideation) is > 2; SI with intent (C-SSRS #4, or #5), regardless of intensity ratings; Suicidal Behavior (any suicide attempt, interrupted attempt, aborted attempt, or suicide preparatory acts or behavior on the C-SSRS).
  • Any medical condition, illness, disorder or concomitant medication that compromises participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
  • Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Gender Based Eligibility:Yes
Gender Eligibility Description:Approximately equal numbers of men and women will participate.
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Larry Hawk716-645-0192[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03262662
Other Study ID Numbers  ICMJE STUDY00000911
R01CA206193 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Larry Hawk, Ph.D., State University of New York at Buffalo
Study Sponsor  ICMJE State University of New York at Buffalo
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Pfizer
Investigators  ICMJE Not Provided
PRS Account State University of New York at Buffalo
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP